Pre-emptive pharmacogenetic testing Other
Conditions
Interventions
This is an observational study recruiting across two study arms, inpatient (IPTIP-I) and outpatient (IPTIP-O). The information gathered at recruitment will be sufficient for the electronic platform to
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be admitted to the Manchester University NHS Foundation Trust or attend an outpatient appointment, as a patient or relative, at the Manchester University NHS Foundation Trust 2. Participants must have the capacity to independently consent 3. Patients must be over the age of 18 years
Exclusion criteria
Exclusion criteria: 1. Patients unable to independently consent 2. Patients under the age of 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with an actionable genotype related to a medicine they are currently, or have previously been, prescribed. Genotype-phenotype relationships will be assigned where there is high-level PharmGKB evidence for clinical actionability (Levels 1A or 1B). This will be expressed as a percentage of the whole study cohort (i.e. number of individuals with an actionable variant receiving a corresponding medicine/the total study cohort). Sub analyses will be undertaken by age and comorbid state. For the inpatient cohort (IPTIP-I) hospital prescriptions will be assessed at a single timepoint during the admission following recruitment. For both cohorts (IPTIP-I and IPTIP-O), Historical GP medicine records will be accessed at a single timepoint after recruitment has closed. Genetic data will be generated for all participants once recruitment has closed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/10/2023: 1. Medicine exposure by British National Formulary (BNF) class will be presented with sub-analysis by age group, sex, and the presence of recorded co-morbidities. Analysis will be presented for the whole cohort, and separately for inpatient and outpatient arms. This will be presented as a percentage of individuals within the whole cohort, or given sub-group, exposed to a particular medicine class. 2. Genotype and metaboliser frequencies, derived using CPIC guidelines, will be presented for the whole cohort. These frequencies, presented as percentages, will then be analysed by age, sex, and ethnicity. 3. Clinical outcomes based on the presence of clinically relevant variants (primary outcome measure) measured using analysis of the patient's healthcare record. For the inpatient cohort (IPTIP-I) hospital prescriptions will be assessed at a single timepoint during the admission following recruitment. For both cohorts (IPTIP-I and IPTIP-O), Historical GP medicine records will be accessed at a single timepoint after recruitment has closed. Genetic data will be generated for all participants once recruitment has closed. Previous secondary outcome measures: 1. Medicine exposure by British National Formulary (BNF) class will be presented with sub-analysis by age group, sex, and the presence of recorded co-morbidities. Analysis will be presented for the whole cohort, and separately for inpatient and outpatient arms. This will be presented as a percentage of individuals within the whole cohort, or given sub-group, exposed to a particular medicine class. 2. Genotype and metaboliser frequencies, derived using CPIC guidelines, will be presented for the whole cohort. These frequencies, presented as percentages, will then be analysed by age, sex, and ethnicity. For the inpatient cohort (IPTIP-I) hospital prescriptions will be assessed at a single timepoint during the admission following recruitment. For both cohorts (IPTIP-I | — |
Countries
England, United Kingdom
Outcome results
None listed